Risk of particulate contamination

Particulate contamination describes the unintended presence of extraneous, mobile and undissolved particles in a parenteral solution. These particles can be of various size,defining them as detectable by visual inspection (in general ≥ 50 μm) or as sub-visible with a range of 2-50 μm in size in general. Especially the sub-visible sized particles demand specific analytical tests for their detection (BSP 2009; USP 2009).

The causes of particulate contamination

Several causes of particulate contaminations of IV fluids are known. This is because drugs are available in various containers (like vials, ampoules, pre-filled containers and premixed solutions) and their usage and manipulations are highly diversified.

Consequently, many types of particle contamination can occur:

uGlass

uPlastic

uRubber

uUndissolved particles/drugs

Glass ampoules especially pose a high risk of particulate contamination, as glass fragments may enter the ampoule when it is opened [Douglas et al. 2001]. If a needle (for example 18G) is used for removing a glass ampoule’s content, small glass particles can pass through the needle into the syringe and easily be injected into patients. This risk remains if drugs are routinely administered via the injection port of the intravenous cannula, which is a safety measure designed to decrease sharps injuries to the medical staff [Lye 2003].

Plastic contamination occurs frequently due to particles from the infusion container’s raw material itself and from the injection port due to its usage with sharp items [Walpot et al. 1989]. The insertion of a needle through the stopper of a medication vial or infusion container can shear off a small piece of the stopper. This particle may float in the medication or IV solution. If the particle is small or masked (e.g. by the label, a matching background or a colored vial), the contamination may be unnoticed. The particle may then be aspirated into a syringe and injected into a patient [Roth 2007].

Undissolved solids in drugs or parenteral solutions can also be an origin of particulate contamination [Durgan et al. 2004]. A further frequent cause of particles occurs as a consequence of incompatibilities. This is an undesirable reaction between an admixtured drug and the carrier solution, the container or further drugs added to the IV solution itself. Incompatibilities can also be present when various solutions are mixed in infusion lines and catheters for parenteral administration. As one consequence of an incompatibility, precipitations can occur leading to the particulate contamination [Josephson 2006, RCN 2005, Douglas et al. 2001].

The occurrence of contamination was shown by Preston et al.[2004], who identified glass particles bigger than 130 μm in 57 % of the controlled injectable solutions. Additionally, Lye [2003] found in a number of more than 500 glass ampoules an average of 0.22 glass particles per unit. The injection of such particles into the body of the patient is therefore a prominent risk.

Prominent risks of particulate contamination

The particles from plastic, glass or rubber can have unfavorable effects, especially in patients who are already ill. Particles as small as 1.5 μm can cause blockages in patients, whereas particles of 6 μm can cause blockages in healthy subjects

The infusion of glass particles can lead to pulmonary silicotic changes and nodular fibrosis of the liver, spleen and small intestines as a result of foreign body reaction [Lye 2003, Sabon et al. 1989]. Also, glass fragments in drugs have been shown to induce an adult respiratory distress syndrome and pulmonary artery granuloma in immature infants [Yorioka et al. 2006, Puntis et al. 1992, Walpot et al. 1989]. Contamination with silicone particles can lead to granulomatous lung disease [Bowen et al. 1981]. Other complications recorded in association with plastic migration include lung disease [Rodriguez et al. 1989], myocarditis [Kossovsky et al. 1990], and skin rash [Ellenbogen et al. 1975]. These contaminations have been

reported after migration of large volumes of plastic. Little is known about the effect of silicone in humans over a long period. Animal studies demonstrated minimal reactions in the brain [Dewan et al.1995a] and lungs [Dewan et al. 1995b; publications ex Dewan et al.2002]. Rubber complications range from clinically occult pulmonary granulomas to local tissue infarction and pulmonary infarction. [Roth 2007, Lehr et al. 2002].

Particles from plastic, glass or rubber can cause phlebitis and also damage the lungs, kidneys, liver and spleen. Apart from harming patients, this may lead to additional treatment costs as well as extended duration of hospital stays.

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